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FDA Approves Co-Pack of Ribociclib and Letrozole for Metastatic Breast Cancer

Posted: Monday, May 15, 2017

On May 8, 2017, the U.S. Food and Drug Administration (FDA) granted approval of the Kisqali Femara Co-Pack (ribociclib and letrozole tablets) for the treatment of postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer. This combination pack is the first of its kind in advanced breast cancer.

This new packaging enables patients to obtain a full 28-day cycle of these two agents with one prescription as well as one co-payment. The co-pack is available in three strengths: ribociclib at 600 mg plus letrozole at 2.5 mg, ribociclib at 400 mg plus letrozole at 2.5 mg, and ribociclib at 200 mg plus letrozole at 2.5 mg.

Ribociclib was approved by the FDA in March 2017 in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor–positive/HER2-negative advanced or metastatic breast cancer. In February 2001, the aromatase inhibitor letrozole was approved as a first-line treatment of postmenopausal women with hormone receptor–positive or –unknown locally advanced or metastatic breast cancer.